Senior Clinical Research Specialist

<p style="text-align:left"><b>Work Shift:</b></p>DAY<div><div><div><div><div><div><div><p style="text-align:left"><b>Work Schedule:</b></p></div></div></div></div></div></div></div><div><div><div></div></div></div><p style="text-align:left"><b>Why Merit?</b></p><p style="text-align:inherit"></p><p style="text-align:left">At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.</p><p><b>ESSENTIAL FUNCTIONS PERFORMED </b></p><p></p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Sets up and maintains trial master file and is responsible for filing and maintaining up to date study documents.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Maintains multiple trackers following the progress of assigned clinical trials, such as essential documents, investigational product, trial supplies and study follow-up visits, as applicable.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Orders, prepares, and sends documents and materials to clinical trial sites and vendors as needed (electronic and paper).</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Provides support to study vendors.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Collects and reviews all regulatory documents for accuracy and compliance to departmental SOPs, local and national regulations and guidelines.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Follows up as required to resolve deficiencies.  </p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Ensures that regulatory documents are maintained and updated in a timely and appropriate manner.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Ensures study team training records are kept current.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Performs in-house duties to assist monitors, e.g., outstanding action items.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Manages central IRB submissions and supports sites in IRB/EC submissions.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> May attend site visits to assist monitors, when applicable.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Assists with the development of study and site tools.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Contributes to clinical site interactions, including enrollment and subject visit updates, clinical trial material and clinical supply requests, issue resolution, etc.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Assists in developing and overseeing study operational plan(s) as applicable (e.g., TMF plan).</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Contributes to study team for trial start-up, conduct, and close-out activities according to industry and departmental standards.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Conducts study systems training(s).</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Contributes to creation of study documentation including informed consent, newsletters, etc.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Provides general support to the Clinical Affairs team and project team(s), including meeting agendas, minutes and management of translations.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Assists Project Managers with invoice receipt and review as applicable.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">          </span> </span></span> Performs other duties and tasks, as required.</p><p></p><p><b>ESSENTIAL <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">PHYSICAL/ENVIRONMENTAL</span> DEMANDS</b></p><p></p><ul><li>Lifting -- Not to exceed 50 lbs. – local practice may apply.</li><li>Writing</li><li>Sitting</li><li>Standing</li><li>Bending</li><li>Visual acuity</li><li>Color perception</li><li>Depth perception</li><li>Reading</li><li>Field of vision/peripheral</li></ul><p></p><p><b>SUMMARY OF MINIMUM QUALIFICATIONS</b></p><ul><li>Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification.</li><li>A minimum of six (6) years of related work experience.</li><li>Current Good Clinical Practice (GCP) certification</li><li>Knowledge of US regulations, Good Clinical Practice and ICH guidelines.</li><li>Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.</li><li>Clinical trial experience.</li></ul><p></p><p><b>PREFERRED QUALIFICATIONS</b></p><ul><li>Medical Device clinical trial experience</li></ul><p></p><p><b>COMPETENCIES</b></p><ul><li>Verbal and written communication</li><li>Organization</li><li>Detail-oriented</li><li>Project task team participation</li></ul><p></p><p><b>COMMENTS</b></p><p></p><p>Infectious Control Risk Category III:</p><p></p><p>The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs.  Risk category III states employment and procedures that do not require exposure.</p><p style="text-align:left">As an eligible Merit employee, you can expect the following:</p><p style="text-align:inherit"></p><p style="text-align:left">* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights</p><p style="text-align:left">* Medical/Dental & Other Insurances (eligible the first of month after 30 days)</p><p style="text-align:left">* Low Cost Onsite Medical Clinic</p><p style="text-align:left">* Two (2) Onsite Cafeterias</p><p style="text-align:left">* Employee Garden | Gardening Classes</p><p style="text-align:left">* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays</p><p style="text-align:left">* 401K | Health Savings Account</p><p style="text-align:inherit"></p><p style="text-align:left">To see more on our culture, go to <a href="http://www.merit.com/careers" target="_blank" rel="noopener noreferrer"><span><span class="WLN2"><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">www.merit.com/careers</span></span></span></a>.</p><p style="text-align:inherit"></p><p style="text-align:left">Military Veterans are encouraged to Apply.</p><p style="text-align:inherit"></p><p style="text-align:left"><b>Merit is a proud Utah Patriot Partner committed to hiring our Veterans.</b></p>

Back to blog

Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...